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mick take a look at
OMQS secured Homeland Security contract today
only 2 million float 4 million OS
that one going higher
in MARA board. Great NK news today. Thanks
in 'NantKwest (NK)'
Thanks mick now do
MARA it's my #2 holding behind NK. Put it on your radar
Great NK News!
These T cells will kill the virus not mask it's receptors.
Oral Vaccine stable at room temperature being tested
3.71 (14.1%) Upgrade to Real-Time
Afterhours (Closed)
ImmunityBio & NantKwest Announce FDA Authorization to Study hAd5 T-Cell COVID-19 Vaccine for Combination of Subcutaneous, Ora...
February 11 2021 - 06:13PM
Business Wire
FDA authorized the expansion of the active Phase 1 COVID-19 vaccine trial and a second trial to test a novel combination of T-cell-based hAd5 subcutaneous prime vaccine with a room-temperature oral or sublingual boost, to induce comprehensive immune protection through CD4+ and CD8+ T cells to both Spike (S) and Nucleocapsid (N) antigens, as well as generate systemic and mucosal antibodies
The first COVID-19 trials conducted to deliver both S and N proteins via multiple routes (skin, gut, or under the tongue) to activate the entire immune system and drive T-cell and B-cell memory, which are required for long-term immune protection
Oral, room-temperature boost that stimulates immunity to both S and N proteins could potentially serve as a universal boost to other S-based vaccines while also targeting escape mutants
Testing of novel combination of oral boost to subcutaneous prime is based on positive NIH/BARDA-sponsored non-human primate data showing potent T-cell and antibody response to hAd5 after oral boost, with rapid inhibition of virus replication to undetectable levels following SARS-CoV-2 challenge
ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have received FDA authorization to expand Phase I testing of a bivalent hAd5 T-cell COVID-19 vaccine. The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts. The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration. As a result, the companies will enroll another 105 participants in the U.S. trials of their vaccine candidate, which is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus.
The expectations of inducing protective immune responses in healthy volunteers – with this novel combination of an oral boost with a subcutaneous prime – are based on the positive findings reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study. This recent data showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of S- and N-specific T cells with potent antibody release from memory B cells following viral challenge. Additionally, activation of the full immune system by S and N proteins resulted in complete viral clearance of SARS-CoV-2 in lung and nasal passages following the challenge. On the basis of these findings, ImmunityBio has expanded the current Phase 1 study of subcutaneous prime with oral or sublingual boost to explore the potential of this second-generation vaccine to reduce disease and transmission of the virus.
The oral trial is a new study (NCT04732468) and the sublingual trial is the cohort C expansion to the Phase 1 subcutaneous trial (NCT04591717), which was initiated last Fall. Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California. Based on the findings of these trials involving over 100 participants, the optimal combination of route of administration and dose will be determined and entered into the Phase 2 / 3 design.
“The NHP study findings reinforce our hypothesis that a T-cell-based vaccine could be protective, not only in preventing mild, moderate, and severe disease, but also in potentially limiting transmission of the virus,” said Patrick Soon-Shiong, MD, Chairman and CEO of ImmunityBio. “We believe that the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to create a vaccine that activates not only antibodies but also memory B and T cells to multiple antigens. Furthermore, room-temperature stable formulations for oral delivery have the potential to solve the cold-chain challenges of distribution and the ability to generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.”
One Vaccine, Two Trials, Three Routes of Immune Protection
The first two cohorts of the Phase Ib, open label, dose-ranging study (NCT04591717) of the vaccine received two different dose levels (.5 and 1ml). Participants received two subcutaneous injections 21 days apart. No grade three or four AEs and no SAEs were observed at either dose level and, in the intermediate (1ml) dose group, immunogenicity was observed as early as 14 days after the prime. An additional group of 40 subjects will be enrolled to evaluate safety, reactogenicity, and immunogenicity of the combination of hAd5 in four different cohorts receiving sublingual and subcutaneous formulations to select an optimal combination dose for future studies.
The second Phase 1b trial (NCT04732468) is designed to assess the safety, reactogenicity, and immunogenicity of the combination of hAd5 in oral capsule and subcutaneous formulations; and to select an optimal combination dose for future studies. Up to 65 subjects will be enrolled in the four-cohort study, which is anticipated to begin in Q1.
About the T-Cell-Based Vaccine Candidate
Developed by ImmunityBio and manufactured by NantKwest, this second generation hAd5 vectored vaccine is unique in targeting both spike (S) and nucleocapsid (N) SARS-CoV-2 proteins to generate B and T cell memory to these antigens and long-term immunity to the virus. Most of the COVID-19 vaccines approved by the FDA or in late-stage clinical trials deliver only the spike protein, which has already mutated several times. Another unique characteristic of the hAd5 design is its use of a second-generation hAd5 platform that was developed to elicit anti-SARS-CoV-2 immune responses even in Ad-immune individuals, meaning subjects can receive the vaccine multiple times, if necessary. The stimulation of anti-hAd5 immune responses is attenuated with the second-generation platform in comparison with the first-generation platforms, due to additional genetic deletions. The hAd5 room temperature-stable oral capsules were developed in partnership with UK-based biotechnology company iosBio.
Phase I trials have been initiated in the U.S. and recruitment is set to begin in February in Cape Town, South Africa for a trial (NCT04710303) of subcutaneous administration to be followed by additional trials using sublingual delivery and room temperature-stable oral capsules.
NantKwest Transaction
As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest (NASDAQ: NK). The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.
About ImmunityBio
ImmunityBio, Inc. is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T-cell) immune systems to create long-term “immunological memory.” This novel approach is designed to eliminate the need for high-dose chemotherapy, improve upon the outcomes of current CAR T-cell therapies, and extend beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). The company is also in Phase 2 or 3 trials for indications such as first- and second-line lung cancer, triple-negative breast cancer, metastatic pancreatic cancer, recurrent glioblastoma, and soft tissue sarcoma in combination with the company’s synthetic immune modulator (Aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus (hAd5) vaccine technologies.
About NantKwest
NantKwest (NASDAQ: NK) is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cells—as well as their activity against a broad range of cancers—has been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwest’s goal is to transform medicine by bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit www.nantkwest.com.
Forward-Looking Statements
The "Pill" NOW being tested in S. Africa:
https://www.researchprofessionalnews.com/rr-news-uk-innovation-2021-2-covid-vaccine-pill-enters-clinical-trials/
IT COULD IN THESE MARKETS $NK
I like NK to 100 see FATE
Market looking a bit shaky. We shall see
MUX has high action coming
Definitely put on radar. Big volume last week.
If Copper project
in Argentina gets funded or Spun out
SP could do something stupid. Gold and silver need to break old highs.
NantKwest Executive Chairman Dr. Patrick Soon-Shiong to Present at 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021 -
https://finance.yahoo.com/news/nantkwest-executive-chairman-dr-patrick-140000875.html
NK
[-chart]www.stockscores.com/chart.asp?TickerSymbol=NK&TimeRange=180&Interval=w&Volume=1&ChartType=CandleStick&Stockscores=1&ChartWidth=1100&ChartHeight=480&LogScale=&Band=&avgType1=&movAvg1=&avgType2=&movAvg2=&Indicator1=None&Indicator2=None&Indicator3=None&Indicator4=None&endDate=&CompareWith=&entryPrice=&stopLossPrice=&candles=redgreen[/chart]
WKLY
Motley Fool just came out saying they like NK better than FATE. However, NK still not in their top-ten.
Experience... on the 22nd NK reached a 5 year high. If you're under the impression that charts go straight up you're sadly mistaken.
And that pull back to the high $13 was how I felt at the time of writing.
A year ago in November NK was trading near a buck and just finished a 20 fold run to near $20? At this point now that the momentum has died off I'm not even looking to trade NK again. GL
Experience... on the 22nd NK reached a 5 year high. If you're under the impression that charts go straight up you're sadly mistaken.
And that pull back to the high $13 was how I felt at the time of writing.
A year ago in November NK was trading near a buck and just finished a 20 fold run to near $20? At this point now that the momentum has died off I'm not even looking to trade NK again. GL
why? what evidence do you offer to back that up?
* * $NK Video Chart 12-22-2020 * *
Link to Video - click here to watch the technical chart video
Missed it. Anything material?
Wonder how clays shorters are doing?
CEO ON MSNBC NOW
* * $NK Video Chart 12-21-2020 * *
Link to Video - click here to watch the technical chart video
News will launch NK! BUT
I suspect not until institutions push out all of the retailers
then make them chase it. It's what they do.
NK could reach the Nov 2015 highs just under $20! I'm still out but if you're in this could run another $2 easy!
Didn't like that second red 1 min candle after breaking $17. but if NK hits my entry target I'll be back in. otherwise had a nice gain.
Looking for a pull back now to the high $13's
Awesome! Nice move to $17!
If NK breaks out above $16.88 I'll be committing more cash!
Grabbed $14.50's here NK is looking to go parabolic.
If it fills the gap it should go to 20
3:05a ET 12/21/2020 - BusinessWire
ImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company
Mentioned: NK
ImmunityBio, a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have entered into an agreement to merge in a stock-for-stock transaction. The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.
Non mRNA tech that is effective front and back
can be boosted in pill form.
Stable at room temperature. Boost T cells.
Cancer treatments in the pipe.
She's wound up pretty tight. Something brewing?
RIP Alex Trebec...
RIP Alex Trebec...
I believe many distrust mRNA vaccines
rushed into production and no long term data.
More conventional T-Cell inducing drugs like NK
could fill a very large gap.
I know I know conspiracy theory right. Many I've talk to will
not take that vaccine.
Take a look at FATE
NantKwest Inc (NK)
11.0 ? 1.56 (16.53%)
Volume: 1,308,296 @12/07/20 1:00:40 PM EST
Bid Ask Day's Range
11.0 11.03 9.46 - 11.24
NK Detailed Quote
Big move while last Fri. while sharks were on vacation
Next few weeks could be interesting
ImmunityBio, NantKwest Announce Positive Interim Phase 1 Safety Data of hAd5 COVID-19 Vaccine Dose Study -
https://www.businesswire.com/news/home/20201110005542/en/ImmunityBio-NantKwest-Announce-Positive-Interim-Phase-1-Safety-Data-of-hAd5-COVID-19-Vaccine-Dose-Study
Dr. Soon-Shiong was interviewed on Fox Business this am.
NK
NantKwest Inc (NK)
7.85 ? 0.32 (4.25%)
Volume: 271,704 @11/03/20 10:57:57 AM EST
Bid Ask Day's Range
7.8 7.85 7.4601 - 7.93
NK Detailed Quote
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